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Bioanalytics
Keynote

Keynote: The Evolving Bioanalytical Strategies and Considerations for Advancing Gene and Cell Therapy Drug Development

Wednesday, November 12, 2025
1:30 PM - 2:30 PM CT
Location:221 AB

Bioanalytics

The rapid advancement of gene and cell therapies necessitates innovative bioanalytical strategies due to the complexity of these drug products and their diverse delivery systems. This presentation explores evolving bioanalytical methods and considerations to address challenges in companion diagnostic development for patient screening, drug-interference-free anti-transgene product antibody assays for lysosomal storage diseases, and safety biomarker assessments for gene and cell therapies. Emerging technologies, platform assays and collaborative standardization are crucial for ensuring the safety and efficacy of novel therapies.

Learning Objectives:

  • Upon completion, participants will be able to learn the recent evolvement of bioanalytical strategies supporting gene and cell therapy drug development.
  • Upon completion, participants will be able to learn how to tackle some of the challenging bioanalytical requirements addressing preclinical and clinical study objectives.
  • Upon completion, participants will be able to learn novel bioanalytical methods developed for gene and cell thearpy studies.